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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007151
Receipt No. R000008421
Scientific Title Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Date of disclosure of the study information 2012/01/30
Last modified on 2017/04/11

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Basic information
Public title Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Acronym Clinical investigation of PTH for implanted spinal surgery
Scientific Title Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Scientific Title:Acronym Clinical investigation of PTH for implanted spinal surgery
Region
Japan

Condition
Condition Osteoporosis with vertebral degeneration
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effect of PTH to induce bony fusion, decrease pseudoarthrodesis or loosening of pedicle screws, and improve clinical symptoms for aged lumbar degenerative diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Fusion rate
Intervertebral disc narrowing and instability
Appearance rate of screw loosening
Key secondary outcomes ADL and QOL
femoral bone mineral density
bone metabolic markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Teriparatide treatment (6 months)
Interventions/Control_2 Non-treatment (6 months)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Patients with lumbar degenerative disease and surgical indication for one level PLIF or TLIF.
2. Patients limited only female and more than 50 years-old.
3. Patients less than 80% YAM of any site examined by DXA, or patients with fragility fracture at any site, for example on lumbar spine, femur, radius or humerus.
Key exclusion criteria 1) The following patients considered to be at high risk of developing osteosarcoma (bone sarcoma).
-Patients with Paget's disease of the bone.
-Patients with high alkaline phosphatase of unknown cause.
-Patients with history of radiotherapy likely to have affected the bone.
2) Patients with hypercalcaemia.
3) Patients with primary malignant osteosarcoma or metastatic bone tumor.
4) Patients with metabolic bone diseases except osteoporosis (hyperparathyroidism etc.).
5) Patients with a history of hypersensitivity to the constituents of TERIBONE for Subcutaneous Injection or other teriparatide formulations.
6) Women who are pregnant or may become pregnant.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Haro, M.D., Ph.D
Organization University of Yamanashi
Division name Department of Orthopaedic Surgery
Zip code
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL 055-273-6768
Email haro@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Isogai
Organization ASAHI KASEI PHARMA Co.
Division name Medical Affairs Dept.
Zip code
Address 1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL 03-3296-3647
Homepage URL
Email isogai.yb@om.asahi-kasei.co.jp

Sponsor
Institute University of Yamanashi, Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization ASAHI KASEI PHARMA Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Shinshu University, School of Medicine, Department of Orthopaedic Surgery
Hamamatsu University School of Medicine, Department of Orthopaedic Surgery
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/jbjsjournal/subjects/Spine/Fulltext/2017/03010/Role_of_Weekly_Teriparatide_A
Number of participants that the trial has enrolled
Results
Results: Seventy-five patients were randomized to treatment, and 66 patients completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT slices was significantly higher in the teriparatide arm compared with the control arm in the age-adjusted modified intention-to-treat analysis and was significantly higher at 6 months in the per-protocol analysis. Radiographic examinations showed no disc-space narrowing and no intervertebral disc instability. JOABPEQ and ODI results were improved postoperatively in both treatment arms.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 30 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
2015 Year 07 Month 31 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 27 Day
Last modified on
2017 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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